Table 4.
Overview of adverse events (AEs)
| Study 1 | Study 2 Lasofoxifene + paroxetine | |||||
|---|---|---|---|---|---|---|
| Lasofoxifene alone | Lasofoxifene + ketoconazole | Lasofoxifene + fluconazole | Lasofoxifene alone | Paroxetine only days 1–7 | Combination days 8–21 | |
| Number of AEs | ||||||
| All AEs | 8 | 29 | 28 | 8 | 34 | 30 |
| Associated AEs | 1 | 2 | 1 | 4 | 31 | 27 |
| Number of subjects reporting AEs | ||||||
| All AEs | 6 | 12 | 8 | 5 | 10 | 10 |
| Associated AEs | 1 | 1 | 1 | 2 | 10 | 10 |
All AEs are defined as all observed or volunteered AEs regardless of treatment group or suspected causal relationship to study drug. Associated AEs are defined as AEs that were evaluated by the investigator as being definitely, probably or possibly related to study drug.